QIAGEN Acquires Exclusive Licence for Key PI3K gene
By Qiagen, PRNESunday, February 7, 2010
Patent Licensed From Johns Hopkins University for PCR-based Companion Diagnostics for Cancer Treatments
VENLO, The Netherlands, February 8 - QIAGEN (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today
announced that its wholly owned subsidiary DxS has acquired the global and
exclusive licence for biomarker PI3K from Johns Hopkins University to develop
real-time-PCR and endpoint PCR assays. Research has shown that variation in
the PI3K gene could be a key biomarker for use as a companion diagnostic with
certain cancer treatments. The studies suggest that mutations in the PI3K
oncogene are predictive for the success of certain treatments of patients
suffering from lung, breast, colorectal and other cancers. QIAGEN has an
active PI3K assay development and partnering program with pharmaceutical
companies to develop and market tests for new cancer drug candidates.
Financial details were not disclosed.
QIAGEN already markets a PI3K test for research use. This test
is based on real-time polymerase chain reaction (RT-PCR), a widely available
technology to make DNA sequences visible through amplification. The assay,
which uses technology that allows a very significant sensitivity, detects
mutations frequently missed by sequencing methods.
The patent for PI3K mutations in human cancers was initially
filed by researchers at Johns Hopkins who assessed the biomarker during their
evaluation of tyrosine kinase inhibitors targeting the EGFR (Epidermal Growth
Factor Receptor) pathway. Various EGFR inhibiting drugs have shown to be not
effective in cancer patients with mutations in genes of the EGFR pathway
(EGFR, K-RAS, B-RAF etc.). QIAGEN already markets several tests determining
the mutation status in oncogenes. This portfolio includes tests for mutations
of K-RAS and B-RAF, which are indicative for metastatic colorectal, lung and
other cancers. The K-RAS test is CE-marked for companion diagnostic use with
EGFR inhibitors Vectibix(R) and Erbitux(R) and is expected to be submitted
for FDA approval shortly.
"This license agreement is another step forward for QIAGEN and
for the use of novel therapeutics that rely on the widespread availability of
the required PI3K companion diagnostic test", said Peer M. Schatz, CEO of
QIAGEN. "We are looking forward to developing drug-diagnostic combinations
together with pharmaceutical partners for the selection of the right patient
for the right medicine. This concept allows cancer patients to receive better
treatments and can support healthcare systems to provide the most useful
therapies in cost effective ways."
QIAGEN is active in more than 15 partnerships with
pharmaceutical and large biotech companies in the field of personalized
healthcare, including AstraZeneca, Merck, Amgen, Lilly, Boehringer-Ingelheim
and Pfizer. QIAGEN has developed and markets approximately 20 companion
diagnostics assays in personalized healthcare and has a strong pipeline
targeting to further expand this leading franchise.
About Companion Diagnostics (CDx)
Companion Dx are integral to the part of personalized
healthcare which allows physicians to determine patients' potential responses
to drug treatment. These diagnostic tests are developed together with drugs
for particular populations. By testing for specific genetic variations
related to certain biomarkers, health professionals can customize their
treatments to achieve the best possible therapeutic results and avoid
unnecessary treatments.
About QIAGEN
QIAGEN N.V., a Netherlands holding company, is the leading
global provider of sample and assay technologies. Sample technologies are
used to isolate and process DNA, RNA and proteins from biological samples
such as blood or tissue. Assay technologies are used to make such isolated
bio-molecules visible. QIAGEN has developed and markets more than 500 sample
and assay products as well as automated solutions for such consumables. The
company provides its products to molecular diagnostics laboratories, academic
researchers, pharmaceutical and biotechnology companies, and applied testing
customers for purposes such as forensics, animal or food testing and
pharmaceutical process control. QIAGEN's assay technologies include one of
the broadest panels of molecular diagnostic tests available worldwide. This
panel includes the digene HPV Test, which is regarded as a "gold standard" in
testing for high-risk types of human papillomavirus (HPV), the primary cause
of cervical cancer, as well as a broad suite of solutions for infectious
disease testing and companion diagnostics. QIAGEN employs more than 3,500
people in over 30 locations worldwide. Further information about QIAGEN can
be found at www.qiagen.com/.
QIAGEN SAFE HARBOR STATEMENT
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forward-looking statements, including statements about our products, markets,
strategy and operating results. Such statements are based on current
expectations that involve risks and uncertainties including, but not limited
to, those associated with: management of growth and international operations
(including currency fluctuations and logistics), variability of our operating
results, commercial development of our markets (including applied testing,
clinical and academic research, proteomics, women's health/HPV testing,
molecular diagnostics, personalized healthcare and companion diagnostics),
our relationships with customers, suppliers and strategic partners,
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requirements, identifying, developing and producing integrated products
differentiated from our competitors' products, market acceptance of our
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further information, refer to our filings with the SEC, including our latest
Form 20-F. Information in this release is as of the date of the release, and
we undertake no duty to update this information unless required by law.
Contacts:
Dr. Solveigh Mahler Director Investor Relations QIAGEN N.V. +49-2103-29-11710 e-mail: solveigh.maehler@qiagen.com Albert F. Fleury Director Corporate Finance and Investor Relations North America QIAGEN N.V. +1-301-944-7028 e-mail: albert.fleury@qiagen.com Dr. Thomas Theuringer Associate Director Public Relations QIAGEN GmbH +49-2103-29-11826 email: thomas.theuringer@qiagen.com Joanne Cross Marketing Manager DxS - a QIAGEN Company Phone: +44(0)7540-121-673 Email: joanne.cross@qiagen.com
Contacts: Dr. Solveigh Mahler, Director Investor Relations, QIAGEN N.V., +49-2103-29-11710, e-mail: solveigh.maehler at qiagen.com; Albert F. Fleury, Director Corporate Finance and Investor Relations North America, QIAGEN N.V., +1-301-944-7028, e-mail: albert.fleury at qiagen.com; Dr. Thomas Theuringer, Associate Director Public Relations, QIAGEN GmbH, +49-2103-29-11826, email: thomas.theuringer at qiagen.com; Joanne Cross, Marketing Manager, DxS - a QIAGEN Company, Phone: +44(0)7540-121-673, Email: joanne.cross at qiagen.com
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